a study of dengue vaccine in healthy toddlers aged 12 to 15 months in the philippines

Conditions: Dengue Fever; Dengue Hemorrhagic Fever

Summary: the purpose of this study is to investigate the potential for co-administration of the first dose of cyd dengue vaccine with childhood vaccination. primary objectives: * to describe the safety of cyd dengue vaccine after each dose; first dose given alone or coadministered with childhood vaccines. secondary objectives: * to describe the immunogenicity of cyd dengue vaccine after each dose; first dose given alone or co-administered with childhood vaccines.

participants will be enrolled in a 3-step enrollment and randomized to 1 of 4 treatment groups. groups 1 and 2 will receive 5 vaccinations, and groups 3 and 4 will received 6 vaccinations (childhood vaccines or placebo co-administered with the first dose of cyd dengue vaccine in 2 separate arms). all toddlers will receive a pentavalent acellular pertussis combination vaccine or combo (pentaxim®), planned approximately 10 months after enrollment.

Eligibility criteria:
inclusion criteria : * toddler in good health based on medical history and medical examination * toddler aged 12 to 15 months on the day of inclusion * born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * provision of informed consent form signed by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations) * participant and parent/delegate able to attend all scheduled visits and comply with all trial procedures * completion of previous vaccination program according to the national immunization schedule, except for measles exclusion criteria : * family members from the investigator or from the staff involved in the trial * chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * history of central nervous system disorder or disease, including seizures * history of varicella, measles, mumps, rubella and hepatitis a; confirmed either clinically, serologically, or microbiologically * thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion * previous vaccination against measles-mumps-rubella, hepatitis a or varicella * previous vaccination against flavivirus diseases * known systemic hypersensitivity to any of the components of the vaccines, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * planned participation in another clinical trial during the present trial period * participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination * receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response * planned receipt of any vaccine in the 4 weeks following the first trial vaccination * human immunodeficiency virus (hiv) seropositivity in the blood sample taken at screening * clinically significant laboratory abnormalities, as judged by the investigator, in blood sample taken at screening temporary exclusions: vaccination postponed until the condition is resolved: * febrile illness (temperature ≥ 38°c) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment * receipt of oral or injected antibiotic therapy within 72 hours prior to the vaccination visit * any vaccination received in the 4 weeks preceding vaccination

Keywords: dengue fever dengue hemorrhagic fever cyd dengue vaccine toddlers